Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain

The research has demonstrated separately that phototherapy and osteopathic manipulative
medicine (OMM) are effective in reducing chronic low back pain, However there has not been
any research to evaluate whether the interaction of the two treatment approaches together can
provide enhanced pain relief. In A Meta-analysis of the Efficacy of Phototherapy in Tissue
Repair, Fulop et.al.(1) from the Department of Physical Therapy, School of Health
Professions, New York Institute of Technology (NYIT) concluded that "phototherapy is a highly
effective form of treatment for tissue repair, with stronger supporting evidence resulting
from experimental animal studies than human studies" (Fulop, p. 695, 699). Further review of
the literature by Fulop et. al. (2) focused on the question of pain relief in relation to
phototherapy, and the conclusion was that pain from various etiologies can be effectively
relieved by phototherapy. The U.S. Food and Drug Administration has cleared biostimulation
lasers (a.k.a. low level laser therapy [LLLT], cold lasers, soft lasers, or laser acupuncture
devices) for marketing as "adjunctive devices for the temporary relief of pain" (3). Thus,
both health practitioners and the lay public have access to and may potentially obtain and
use phototherapy devices manufactured by various companies. Other research protocols by Gur,
A et. al. (4) and Djavid, GE et. al. (5) evaluated patients with chronic low back pain in
relation to the combined effectiveness of low level laser therapy and exercise. These studies
showed positive results with the combined approaches.

Osteopathic physicians utilize an approach to the treatment of patients called osteopathic
manipulative medicine (OMM). The osteopathic physician will diagnose somatic dysfunction, and
then treat the dysfunctions found with one or more of several OMM treatment approaches. The
American Osteopathic Association (AOA) published in 2009 the "Guidelines for Osteopathic
Manipulative Treatment (OMT) for Patients with Low Back Pain." These guidelines are available
both through the AOA and the Agency for Healthcare Research and Quality (AHRQ), National
Guideline Clearinghouse (6). This guideline (6) specifically addresses the "efficacy of
osteopathic manipulation treatment in reducing low back pain" (p. 2). A review of the
literature was performed, and after selection a total of "six trials, involving eight
osteopathic manipulative treatment (OMT) vs control treatment comparisons, were included" in
the meta-analysis (p. 2-3). The major recommendation stated in the guideline is that
"osteopathic manipulative treatment (OMT) be utilized by osteopathic physicians for
musculoskeletal causes of back pain, i.e., to treat the diagnoses of somatic dysfunctions
related to the low back pain" (p.4). In addition, the meta-analysis performed did show that
OMT for patients with low back pain led to statistically significant reduction in pain (p.
5). Thus, the potential for a complementary approach to patient care in cases of chronic low
back pain exists. Yet, no studies to date have specifically evaluated this particular
hypothesis regarding OMT and phototherapy for patients with chronic low back pain. The
purpose of this research is to evaluate this question of enhanced combined efficacy for the
overall benefit of patients.

Inclusion Criteria:

- Age range: 18 - 65 years old

- Subjects with constant or intermittent nonspecific lower back pain for a minimum of
three (3) months duration.

Exclusion Criteria:

- Prospective subjects with a diagnosis of the following potential underlying causes of
lower back pain: ankylosing spondylitis, cancer or a history of a histologically
demonstrated malignant carcinoma, cauda equine syndrome, herniated disc, spinal
fracture, or spinal osteomyelitis.

- Prospective subjects who have undergone surgery of the lower back in the preceding
three (3) months.

- Prospective subjects who have received worker's compensation in the preceding three
(3) months, or are involved in litigation involving concerns of lower back.

- Prospective subjects who are pregnant.

- Prospective subjects who have been a patient receiving any osteopathic manipulative
medicine (OMM) treatment at the clinical trial site in the previous three (3) months,
or on greater than three (3) occasions in the preceding year.

- Prospective subjects who have ever been an employee at the clinical trial site.

- Prospective subjects who have received spinal manipulation in the previous three (3)
months, or on greater than three (3) occasions in the preceding year.

- Prospective subjects who are currently involved in a physical therapy rehabilitation
program.

- Prospective subjects who have photosensitivity.